Endoluminal fundoplication device and related method

ABSTRACT

A distal assembly of an endoscopic surgical device, and a related method, having a first arm and a second arm pivotal relative to the first arm. Each arm is configured to hold a part of a two-part fastener at a distal end of the arm. A closing mechanism is positioned proximate a proximal end of each of the first and second arms opposite the distal end of each of the first and second arms. The closing mechanism is configured to move in relation to the first and second arms so as to close over at least one of the first and second arms to cause the distal ends of the arms to come together. An actuation member is also attached to the closing mechanism actuable to cause the closing mechanism to move in relation to the first and second arms.

This is a continuation of application Ser. No. 09/863,666, filed May 23,2001, now U.S. Pat. No. 6,916,332 which is incorporated herein byreference.

FIELD OF THE INVENTION

The invention relates to an endoscopic surgical instrument. Moreparticularly, the invention relates to a flexible instrument fortransoral invagination and fundoplication of the stomach to theesophagus.

BACKGROUND OF THE INVENTION

Gastroesophageal reflux occurs when stomach acid enters the esophagus.This reflux of acid into the esophagus occurs naturally in healthyindividuals, but also may become a pathological condition in others.Effects from gastroesophageal reflux range from mild to severe. Mildeffects include heartburn, a burning sensation experienced behind thebreastbone. More severe effects include a variety of complications, suchas esophageal erosion, esophageal ulcers, esophageal stricture, abnormalepithelium (e.g., Barrett's esophagus), and/or pulmonary aspiration.These various clinical conditions and changes in tissue structure thatresult from reflux of stomach acid into the esophagus are referred togenerally as Gastro-esophageal Reflux Disease (GERD).

Many mechanisms contribute to prevent gastroesophageal reflux in healthyindividuals. One such mechanism is the functioning of the loweresophageal sphincter (LES). The LES is a ring of smooth muscle andincreased annular thickness existing in the last four centimeters of theesophagus. In its resting state, the LES creates a region of highpressure (approximately 15-30 mm Hg above intragastric pressure) at theopening of the esophagus into the stomach. This pressure essentiallycloses the esophagus so that contents of the stomach cannot pass backinto the esophagus. The LES opens in response to swallowing andperistaltic motion in the esophagus, allowing food to pass into thestomach. After opening, however, a properly functioning LES shouldreturn to the resting, or closed state. Transient relaxations of the LESdo occur in healthy individuals, typically resulting in occasional boutsof heartburn.

The physical interaction occurring between the gastric fundus and theesophagus also prevents gastroesophageal reflux. The gastric fundus is alobe of the stomach situated at the top of the stomach distal to theesophagus. In asymptomatic individuals, the fundus presses against theopening of the esophagus when the stomach is full of food and/or gas.This effectively closes off the esophageal opening to the stomach andhelps to prevent acid reflux back into the esophagus. More specifically,as the food bolus is immersed in gastric acid, it releases gas whichcauses the fundus of the stomach to expand and thereby put pressure onthe distal esophagus causing it to collapse. The collapse of theesophagus lumen reduces the space for the stomach acid to splash pastthe closed esophagus lumen and thereby protect the proximal esophagusfrom its destructive contact.

In individuals with GERD, the LES functions abnormally, either due to anincrease in transient LES relaxations, decreased muscle tone of the LESduring resting, or an inability of the esophageal tissue to resistinjury or repair itself after injury. These conditions often areexacerbated by overeating, intake of caffeine, chocolate or fatty foods,smoking, and/or hiatal hernia. Avoiding these exacerbating mechanismshelps curb the negative side effects associated with GERD, but does notchange the underlying disease mechanism.

A surgical procedure has been developed to prevent acid reflux inpatients whose normal LES functioning has been impaired. This procedure,a Nissen fundoplication, involves bringing the fundus into closerproximity to the esophagus and suturing the fundus thereto, to helpclose off the esophageal opening into the stomach. Traditionally, thisprocedure has been performed as an open surgery, but also has beenperformed laparoscopically.

As with any surgery, the attendant risks are great. The Nissenfundoplication is a very difficult procedure to complete and thus thepatient is anesthitized for a long time. Due to relatively largeincisions necessary in the performance of open surgery, relatively largeamounts of blood are lost, the risk of infection increases and thepotential for post-operative hernias is high.

A laparoscopic procedure may involve performing laparotomies for trocarports (penetrations of the abdominal wall) percutaneous endoscopicgastronomies (incisions through the skin into the stomach) and theinstallation of ports through which, for example, a stapler, anendoscope, and an esophageal manipulator (invagination device) areinserted. Under view of the endoscope, the esophageal manipulator isused to pull the interior of the esophagus into the stomach. When theesophagus is in position, with the fundus of the stomach plicated, thestapler is moved into position around the lower end of the esophagus andthe plicated fundus is stapled to the esophagus. The process may berepeated at different axial and rotary positions until the desiredfundoplication is achieved. This procedure is still relatively invasiverequiring incisions through the stomach, which has a risk of infection.The location of the incision in the abdominal wall presents a risk ofother negative effects, such as sepsis, which can be caused by leakageof septic fluid contained in the stomach.

Less invasive treatments of gastroesophageal reflux disease may utilizea remotely operable invagination device and a remotely operable surgicalstapler, both of which are inserted transorally through the esophagus.The invagination device may be inserted first and used to clamp thegastroesophageal junction. The device is then moved distally, pullingthe clamped gastroesophageal junction into the stomach, therebyinvaginating the junction and involuting the surrounding fundic wall.The stapler then may be inserted transorally and delivered to theinvaginated junction where it is used to staple the fundic wall. Thestapling device must apply sufficient force to pierce the tissue that isto be fastened.

SUMMARY OF THE INVENTION

In accordance with one aspect of the invention, a distal assembly of anendoscopic surgical device is provided having a first arm and a secondarm pivotal relative to the first arm. Each arm is configured to hold apart of a two-part fastener at a distal end of the arm. A closingmechanism is positioned proximate a proximal end of each of the firstand second arms opposite the distal end of each of the first and secondarms. The closing mechanism is configured to move in relation to thefirst and second arms so as to close over at least one of the first andsecond arms to cause the distal ends of the arms to come together. Anactuation member is also attached to the closing mechanism and isactuable to cause the closing mechanism to move in relation to the firstand second arms.

According to another aspect of the invention, a tissue fastening tool isutilized with an endoscope. The endoscope is provided with a stopmechanism to come in contact with the distal assembly and stop thedistal assembly at a predetermined location along the endoscope.

According to yet another aspect of the invention, an endoscope may beprovided with a housing that contains two light and imaging systems, onefacing in a distal direction and the other facing in a proximaldirection opposite the distal direction.

Another aspect of the invention includes a method for fasting tissuethat includes guiding a tissue fastening tool along an endoscope untilthe tissue fastening tool contacts a stop mechanism so as to positionthe tissue fastening tool relative to the endoscope. The tissuefastening tool has a pair of arms and each of the arms holds a part of atwo-part fastener. The operator then positions the pair of arms aboutthe tissue to be fastened and the arms are then closed to deploy thetwo-part fastener and fasten the tissue.

According to another aspect, the invention includes a method forfastening tissue that includes guiding a tissue fastening tool through abody lumen to tissue to be fastened. The tissue fasting tool includes apair of arms, each arm holding a part of a two-part fastener. The pairof arms is then positioned about the tissue to be fastened. A closingmechanism is then actuated to close over at least one of the arms tocause the arms to come together and the parts of the two-part fastenerto mate and fasten the tissue.

Additional objects and advantages of the invention will be set forth inpart in the description which follows, and in part will be obvious fromthe description, or may be learned by practice of the invention. Theobjects and advantages of the invention will be realized and attained bymeans of the elements and combinations particularly pointed out in theappended claims. The foregoing general description and the followingdetailed description are exemplary and explanatory only and are notrestrictive of the invention, as claimed.

BRIEF DESCRIPTION OF THE DRAWINGS

The accompanying drawings, which are incorporated in and constitute apart of this specification, illustrate embodiments of the invention andtogether with the description, serve to explain the principles of theinvention.

FIG. 1 is a plan view of a distal end of a fastener application toolaccording to an embodiment of the present invention.

FIG. 2 is a view of the fastener application tool of FIG. 1 affixed to asleeve and in place over an endoscope.

FIG. 2A is a cross-sectional view along line A-A of the fastenerapplication tool of FIG. 2 that has been rotated 90° from theorientation shown in FIG. 2.

FIG. 3 is a view of the fastener application tool of FIG. 1 in placeover an endoscope and having a stop ring to accurately position the toolfor performing the surgical procedure.

FIG. 4 is a view showing the fastener application tool and endoscope ofFIG. 2, with the tool in a deployed position inserting a fastenerthrough the tissue.

FIG. 5 is a plan view of a distal end of an endoscope according to anembodiment of the present invention.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

Reference will now be made in detail to the present preferred andexemplary embodiments of the invention, examples of which areillustrated in the accompanying drawings. Wherever possible, the samereference numbers will be used throughout the drawings to refer to thesame or like parts.

FIG. 1 shows a distal end of a tissue fastener application tool 10according to an embodiment of the present invention. In this figure,tool 10 is in an intermediate position between a fully open position anda deployed position where the tool deploys a fastener to secure a tissuefold. Tool 10 preferably is used endoscopically, by insertiontransorally through the esophagus, to fasten the fundic wall with atissue fastener. Tool 10 includes a pair of pivot arms 12, 14 configuredto pivot about a pivot point 16 located at a proximal end of arms 12,14. Beneath arm 12 is located flange 11. Flange 11 is preferably shapedto fit into a groove located within sleeve 30 (shown in FIG. 2A). Thisflange and groove is depicted in FIG. 2A as a dove-tail joint, but maybe any other mating configuration known in the art. At a distal end ofarm 12 is a holding mechanism for holding a female part 40 of a two-parttissue fastener. Likewise, at the distal end of arm 14 is a holdingmechanism to hold a male part 42 of the two-part tissue fastener. Thefemale and male fastener parts 40,42 could be located on either pivotarm and are not intended to be limited to the configuration disclosed inthe drawings. The two-part tissue fastener and its holding mechanismsmay take the form of any suitable tissue fastener and holding mechanismknown in the art, including, for example, holding mechanisms thatinclude storage for housing multiple fastener parts.

Tool 10 further includes a closing tube 18 positioned over the proximalend of pivot arms 12, 14 where the arms intersect at pivot point 16. Aspring device may be located at pivot point 16 to supply a spring forceto normally hold arms 12,14 in an open position when closing tube 18 isin a retracted position, such as that shown in FIG. 3. Arm 12 preferablyis in a fixed position relative to tube 18 and arm 14 rotates from anopen position (FIG. 3) to a closed position (FIG. 4) relative to arm 12.Tube 18 is hollow to accommodate arms 12,14 and the full span ofrotation of arm 14.

Closing tube 18 is connected to an elongate actuator, such as a cable20, which connects to a proximal actuator (not shown) of any suitabletype well known in the art, so that a user may pull a proximal end ofcable 20 that is outside the patient, or actuate a proximal actuator todo so, to pull tube 18 toward the distal ends of pivot arms 12,14 andthus over arms 12,14. This causes arm 14 to pivot at point 16 andtowards arm 12 to cause fastener parts 40,42 to mate and secure a tissuefold. Arm 12 is provided with a channel 13 into which the base ofclosing tube 18 rests. This channel, along with a matching protrusion 15(FIG. 2A) provided at the base of closing tube 18 provides a path alongwhich closing tube may move to facilitate the closing action that bringsarms 12 and 14 together to deploy fastener parts 40 and 42.

Pivot arm 14 is preferably curved as depicted in the drawings so as toallow closing tube 18 to close more easily and apply sufficient force tothe fastener parts. Also, the inside of closing tube 18 may be providedwith a cam surface 19 that is substantially the same shape as arm 14 toact as a cam and provide an even greater closing force to be applied toarms 12 and 14. Arm 14, however, may be straight or have any othersuitable configuration. In addition, arm 12 may be arranged so that itpivots toward arm 14 when tube 18 is closed. The arrangement of thedistal end of the tool 10 provides a high mechanical advantage on thearms to produce a sufficient closing force.

Tissue fastener application tool 10 preferably is used in combinationwith an endoscope, such as an endoscope 2 according to an embodiment ofthe present invention and shown in FIGS. 2, 3, and 4. Endoscope 2preferably is a small diameter endoscope that incorporates featuresneeded for the surgical procedure, for example visualization (includingimaging and a light source), insufflation, and/or steerability.Additional endoscope features, such as working channels for a biopsydevice, may be eliminated so that the endoscope size is reduced,permitting the tissue fastener application tool to pass adjacent theendoscope within the lumen of the esophagus. Endoscope 2 may beapproximately 3 mm in diameter, for example and include a light source 3at its distal end that is capable of illuminating the uppergastrointestinal region. Endoscope 2 may also include an appropriatesteering mechanism so that the distal end of the endoscope may be turned180 degrees upon entry into the stomach, as shown in FIGS. 2, 3 and 4.

In another embodiment shown in FIG. 5, endoscope 2 may includealternative light and imaging/camera assembly 60. Rather than requiringthe endoscope to curve around at the distal end through use of asteering mechanism, endoscope 2 could have light and imaging/cameraassembly 60, in the form of a housing, at the distal end that allowsboth forward viewing as endoscope 2 is inserted into the stomach as wellas rearward viewing to allow the operator to see the procedure onceendoscope 2 is in the proper position. Assembly 60 may include astandard camera and light source 62 pointing away from the distal end ofassembly 60 and also a second camera and light source 64 that branchesoff of endoscope 2 and points rearward (or proximally) toward the toolto be used in the procedure. A user may switch imaging and light througha suitable switch at the proximal end outside the patient between theseforward and rearward views. This configuration allows for a streamlinedendoscope and does not require the operator to change the position ofthe distal end of endoscope 2 to bring it from a forward pointingposition during insertion to a rearward pointing position during theprocedure.

In an embodiment, endoscope 2 may be used as a guide, like a guide wire,for the insertion of the tissue fastener application tool, as will beexplained. Endoscope 2 also may include a stop, such as that shown inFIGS. 2, 3, and 4, in the form of, for example, a ring 6 configured toset the position of tool 10 relative to endoscope 2.

In operation, and according to an embodiment of a method of the presentinvention, endoscope 2 is inserted transorally, through the esophagus,and into the stomach. Endoscope 2 is manipulated so that the imaging andlight source is in a position to view the esophagus and upper portionsof the stomach, as shown in FIGS. 2, 3, and 4. If an endoscope having adistal assembly as shown in FIG. 5 is used, camera and light source 64is switched on to view those portions of the gastrointestinal tract. Thetissue fastener application tool 10 then is inserted into the esophagusalong endoscope 2.

As tool 10 is inserted through the esophagus and into the stomach, arms12,14 preferably are in a closed position. Tool 10 is inserted until aportion of the distal end of sleeve 30 abuts against stop ring 6 ofendoscope 2 so that tool 10 is at an appropriate position relative toendoscope 2 and its imaging and light assembly. Once tool 10 is inposition, tube 18 is moved over arms 12,14 and towards the proximal endsof arms 12, 14 to rotate arm 14 to an open position away from arm 12.Endoscope 2 and tool 10 can then be moved proximally as a unit so thatarms 12,14 are opened about a tissue fold 50 that is to be fastenedtogether, as shown in FIG. 3.

During insertion, cable 20 is actuated to keep tube 18 over arms 12,14to maintain this closed position. Because tool 10 is preferably in aclosed position during insertion, a spring may be provided in channel 13that would bias tube 18 into an open position once cable 20 is released.Once the tool is in position, the operator may pull cable 20, thuscausing closing tube 18 to move toward the distal ends of arms 12,14. Astube 18 moves closer to the distal ends of arms 12,14, force is applieduntil the two fastener parts 40, 42 are brought together in a matedposition as seen in FIG. 4. As closing tube 18 is actuated by pullingcable 20, it will counteract the force of the spring at pivot 16 andbring pivot arms 12, 14 together to mate the fastener parts 40, 42.

According to an embodiment of the this invention, tube 18 may include analternative assembly for closing arms 12,14. Instead of cable 20 beingused to pull closing tube 18 to cause pivot arms 12,14 to close, cable20 may be replaced with a flexible shaft having a threaded distal endthat is inserted into a threaded hole in tube 18. In this configuration,the flexible shaft is rotated in one direction to cause the threadedportions of both the shaft and closing tube 18 to work together to drawclosing tube 18 toward the distal ends of pivot arms 12,14 to causefastener parts 40,42 to mate. Cable 20 may then be rotated in theopposite direction to move closing tube 18 distally away from arms 12,14, thus allowing arms 12, 14 to move apart again. Tube 18 may includeany other suitable alternative actuation mechanism that moves tube 18over arms 12, 14.

Other embodiments of the invention will be apparent to those skilled inthe art from consideration of the specification and practice of theinvention disclosed herein. The specification and examples are exemplaryonly, with a true scope and spirit of the invention being indicated bythe following claims.

1. A method for fastening tissue, comprising the steps of: guiding atissue fastening tool with a distal end and a proximal end through anatural orifice of a body along an endoscope until the distal end of thetissue fastening tool contacts a stop mechanism to prevent furtherdistal motion of the tissue fastening tool relative to the endoscope soas to position the tissue fastening tool relative to the endoscope,wherein the tissue fastening tool includes a pair of arms, each armholding a part of a two-part fastener; positioning the pair of armsabout the tissue to be fastened; and actuating a closing mechanism tomove over the arms so as to close the arms to deploy the two-partfastener and fasten the tissue, wherein the stop mechanism permitsproximal motion of the tissue fastening tool relative to the endoscopewhen the tissue fastening tool and the endoscope are inside the body,and wherein the closing mechanism is positioned such that the closingmechanism extends distally of the arms.
 2. The method of claim 1,further comprising turning a distal end of the endoscope to face thetissue fastening tool and the tissue to be fastened.
 3. The method ofclaim 1, further comprising the step of switching from a first lightsource and imaging system of the endoscope that faces a distal directionand a second light source and imaging system of the endoscope that facesa proximal direction opposite the distal direction.
 4. The method ofclaim 1, wherein actuating the closing mechanism includes pulling on acable attached to the closing mechanism.
 5. The method of claim 1,wherein actuating the closing mechanism includes rotating a shaft with athreaded end that is coupled to the closing mechanism.
 6. The method ofclaim 1, wherein the pair of arms are in a substantially closedconfiguration during the guiding step.
 7. The method of claim 6, furthercomprising the step of opening the arms prior to the positioning step.8. The method of claim 1, wherein the closing mechanism provides a forceto an outer surface of at least one of the arms to cause the arms tocome together.
 9. The method of claim 1, wherein the tissue fasteningtool is configured such that it substantially surrounds the endoscopeduring the guiding step.
 10. A method for fastening tissue, comprisingthe steps of: guiding a tissue fastening tool through a natural orificeof a body and into a body lumen to tissue to be fastened, wherein thetissue fastening tool includes a pair of arms, each arm holding a partof a two-part fastener; positioning the pair of arms about the tissue tobe fastened; and actuating a closing mechanism in a proximal directionrelative to the pair of arms to close over at least one of the arms tocause the arms to come together and the parts of the two-part fastenerto mate and fasten the tissue; wherein the actuating step includes atleast one of pulling on an elongate actuator attached to the closingmechanism and rotating a shaft coupled to the closing mechanism, andwherein the closing mechanism is positioned such that the closingmechanism extends distally of the arms.
 11. The method claim of claim10, wherein actuating the closing mechanism includes pulling on a cableattached to the closing mechanism.
 12. The method claim of claim 10,wherein actuating the closing mechanism includes rotating a flexibleshaft with a threaded end coupled to the closing mechanism.
 13. Themethod of claim 10, wherein the arms are in a substantially closedconfiguration during the guiding step.
 14. The method of claim 13,further comprising the step of opening the arms prior to the positioningstep.
 15. The method of claim 10, wherein the guiding step includesguiding the tissue fastening tool along an endoscope.
 16. The method ofclaim 15, wherein the tissue fastening tool is guided along theendoscope in a proximal direction and in a distal direction.
 17. Themethod of claim 15, wherein the tissue fastening tool is configured suchthat it substantially surrounds the endoscope during the guiding step.18. The method of claim 10, wherein the closing mechanism provides aforce to an outer surface of at least one of the arms to cause the armsto come together.